Study on Mitotane With or Without Cisplatin and Etoposide After Surgery for Patients With Stage I-III Adrenocortical Cancer at High Risk of Recurrence

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03583710

Provider View

This clinical trial is exploring whether mitotane alone or combined with chemotherapy drugs cisplatin and etoposide is more effective in preventing the return of adrenocortical cancer after surgery in patients at high risk of recurrence.

Patient Parameters

Program Overview

The purpose of this study is to determine if mitotane alone or in combination with chemotherapy drugs cisplatin and etoposide is more effective in preventing the return of adrenocortical cancer after surgery. Mitotane is a medication that reduces cortisol, which can help control tumor growth. Cisplatin and etoposide are chemotherapy drugs that work by killing cancer cells or stopping them from growing and spreading. The study aims to find out which treatment approach is better for patients with adrenocortical cancer that has a high risk of coming back after surgery.

Description

The study is divided into two groups. In one group, patients will take mitotane daily for up to two years, as long as the cancer does not progress and there are no severe side effects. In the other group, patients will also take mitotane daily, but they will receive additional chemotherapy with cisplatin and etoposide every 21 days for up to four cycles, unless the cancer progresses or side effects become too severe.

The main goal is to compare how long patients remain free of cancer recurrence between the two treatment groups. The study will also look at overall survival, the impact of different factors like mitotane levels and timing of treatment start, and any serious side effects. Quality of life will be assessed at various points during the study using a questionnaire.

Researchers will also explore genetic changes in tumor samples to see if they relate to treatment outcomes and look for markers that might predict cancer recurrence or response to treatment.

After completing the study treatment, patients will have follow-up visits every six months to monitor their health.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with adrenocortical cancer (ACC) with a high risk of recurrence after surgery.
  • Cancer must be Stage I-III and have been surgically removed with the intent to cure.
  • No clear evidence of remaining cancer on recent imaging tests.
  • Good overall health with an ECOG performance status of 0-2.
  • Able to follow study procedures and provide written consent.

Exclusion Criteria

  • More than 90 days have passed since surgery.
  • Cancer was not completely removed during surgery.
  • Evidence of cancer spread on recent imaging tests.
  • History of other recent or active cancers, except for certain treated skin or cervical cancers.
  • Poor kidney or liver function, or low blood cell counts.
  • Pregnant or breastfeeding.
  • History of heart failure or significant heart issues.
  • Existing nerve damage or previous treatment with mitotane or other cancer drugs for ACC.
  • Any severe medical or psychiatric condition that could increase risk or make participation inappropriate.

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